Sanofi Group Head, Patient Centered Outcomes in Cambridge, Massachusetts
Job title: Head, Patient Centered Outcomes
Department: Patient Informed Development and Health Value, in the Office of the Development
Position reports to: Head of Health Value Translation
Location: Bridgewater, NJ/ Cambridge MA, USA or Paris, France
Sanofi is focused on ensuring that patient-relevant information is central to decision-making during the clinical development. The Patient Centered Outcomes (PCO) team reports into the Patient Informed Development and Health Value Translation (PID&HVT) function within global development. Within this function the team supports all therapeutic areas in deriving a patient-centric understanding of conditions and measuring relevant concepts of the condition and its treatment in a scientifically robust manner using Clinical Outcome Assessment (COA) instruments (social media listening, patient preference studies, active and passive digital tool, interviews and focus groups). The PCO team has primary focus on:
Developing, assessing, using, interpreting and disseminating COAs, including Patient-Reported Outcomes (PROs), Observer-Reported Outcomes (ObsROs) and Clinician-Reported Outcomes (ClinROs) to derive treatment benefit during the clinical development and commercialization of new molecules (Early Stae). Performance Outcomes (PerfO) are also covered by the COA team, whom also provides increasing support for technology-enabled outcomes.
Supporting the development of COA-based support tools for patients and healthcare professionals in routine clinical practice using digital technologies.
Supporting the development of patient-centric disease area strategies including patient-preference research in close collaboration with HVT and PEL leads
Consultation with regulators, payers and key opinion leaders is common.
Example research activities for the PCO team may include development of a conceptual model of disease through literature reviews, expert clinician interviews and concept elicitation interviews with patients; the systematic selection of COA instruments to measure specific concepts of interest; psychometric assessment of the measurement properties of a COA instrument (reliability, validity, responsiveness etc); development of new COA instruments, including cognitive interviews to ensure content validity; development of briefing books or dossiers for regulatory consideration of COAs for inclusion in product labelling; analysis of textual data from COAs or social media; development of routine clinical practice tools for self-management, shared-decision making and communication; and faithful migration of COA instruments from paper for electronic use. Selected measures should be ‘fit for purpose’ and improve products’ differentiation.
Internal customers include: Global Project Teams (GPTs), Health Economics and Value Assessment (HEVA; previously HEOR), Regulatory, Biostatistics, Pharmacovigilance (for B/R assessments) and Medical Affairs (for observational studies).
Head of Patient Centered Outcomes Role Description:
The Head of PCO is expected to be able to:
Line manage an international team of COA Scientists.
Coordinate the COA function across the development staged portfolio to ensure optimal integration of COA strategy.
Establish broader COA team integration with external PAG activities (per directive of PAG Alliance leader.
Identify new opportunities to integrate PRO/COA strategy further ‘upstream’ in clinical development life cycle (ie Ph I).
Mentor and onboard new COA personnel.
Basic Qualifications & Experience:
Relevant advanced academic degree with expertise in COA methods.
Expertise in clinical trial application of COAs.
At least 5 years of people management experience leading COA related teams either in the pharmaceutical industry or a CRO.
Experience of drug development lifecycle research (including qualitiative and quantitate data sources and application of real-world evidence (RWE) research).
Understanding of regulatory (FDA, EMA, local agencies) and payer (EUnetHTA, NICE, other local agencies) environment, including joint regulatory/HTA review process.
Good interpersonal and communication skills, both written and oral; ability to understand and communicate with representatives from the range of disciplines.
Ability to manage multiple priorities and projects, and balance workload and timelines; Able to work in a fast-paced and dynamic environment.
Ability to work effectively either in small teams or independently.
Ability to interact and manage external and internal networks.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.